Chamber cushion, seal and use thereof

ABSTRACT

A device and method for creating and/or maintain an obstruction free upper airway passage. The device configured to fit under the chin of a subject adjacent to the subject&#39;s at an external location corresponding approximately with the subject&#39;s internal soft tissue associated with the neck&#39;s anterior triangle. The device including structural elements designed to optimize comfort, compliance and seal achieved through minimizing the pressure variation along the contact surface of the cushion element. The structural elements of the cushion may include a fluidly sealed chamber that may vary in thickness and width, a compressible elastic foam contained within the fluidly sealed chamber a ribbon layer backing the elastic foam contained within the fluidly sealed chamber and an adhesive layer disposed on the outer surface of the fluidly sealed chamber of the therapy device designed to contact the skin of the subject.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. provisional applicationNo. 62/260,211, filed Nov. 25, 2015, which is hereby incorporated byreference in its entirety.

BACKGROUND OF THE APPLICATION

The following discussion of the background of the invention is merelyprovided to aid the reader in understanding the invention and is notadmitted to describe or constitute prior art to the present invention.

The external application of negative pressure to patients for palliativeor therapeutic purpose is well established in the medical arts.

U.S. Pat. Nos. 5,343,878, 7,182,082, and 7,762,263 describe variousdevices which purport to utilize external application of negativepressure upon the external neck surface of patients. A therapeuticappliance is typically provided that has a surface which is configuredto enclose an external area of the throat (the term “throat” as usedherein referring to the anterior portion of the neck extendingapproximately from the chin to the top of the sternum and laterally to apoint posterior to the external jugular vein) overlying a portion of theupper respiratory passage. In certain embodiments, these appliances canprovide a chamber (e.g., a hollow space filled with air molecules) lyingbetween the interior surface of the chamber and the throat. The therapyappliance is operably connected to an air pump which is configured toproduce a partial vacuum in this chamber. Application of a therapeuticlevel of negative pressure in the chamber elicits movement of the upperairway and may alleviate conditions such as snoring, sleep apnea, andfull or partial airway collapse for example.

In these “negative pressure” therapeutic apparatuses and methods it isdifficult to obtain a proper and comfortable fit between the apparatusand the patient to create and maintain the differential negativepressure (relative to atmospheric pressure for example) at the desiredlocation on the patient. This is particularly true as the devices areintended for daily wear for many hours; thus, any points of highpressure soon become too uncomfortable for continued use. Further,success of these negative pressure therapies is optimized by a device'sability to accommodate (flex, bend, flow, etc.) varying anatomicalfeatures (i.e. device compliance). Device compliance, also maximizesuser participation through a good comfortable interface between thedevice and the user. Finally, the device should also accommodatemovement to different sleeping positions without loss of seal.

BRIEF DESCRIPTION OF THE INVENTION

It is an object of the invention to provide a cushion element adapted toform a conforming sealing surface between a device that is intended toattach and seal to a patient's external tissue, such as a face, a neck,an area surrounding a wound, etc. This cushion element is particularlysuited for forming a sealed chamber that is configured for theadministration of negative pressure to a targeted therapy on theexternal tissue of an individual. By “external area” as used herein,this refers to a portion of the external skin surface of the individual.in various embodiments, the cushion element is configured to provideoptimized fitting parameters, for example, seal, comfort and localdevice compliance throughout all points of contact. This is preferablyachieved by minimizing the contact pressure differential from one pointof contact on the skin of a patient to another through design featuresof the cushion element of a negative pressure therapy device.

In a first aspect, the present invention provides therapy devicesconfigured for the administration of negative pressure upon the externalsurface of the individual. These therapy devices comprise:

-   a vessel configured to define a chamber at an external location    approximately at the internal soft tissue of the individual    corresponding to the anterior triangle of the neck;-   a cushion element defining a contact area between the individual and    the vessel, the cushion element comprising a first surface thereof    configured to make contact with the skin of the individual when the    therapy device is mated to the individual, and a second surface    there of that is distal from the first surface relative to the    contact area and that, together with the first surface, forms a    fluidly sealed chamber;-   a non-flowing material positioned within the fluidly sealed chamber,    the non-flowing material configured to provide mechanical support to    the fluidly sealed chamber to prevent regional collapse of the    fluidly sealed chamber when the therapy device is mated to the    individual and a therapeutic level of negative pressure is applied    within the vessel;-   a ribbon layer positioned to the non-flowing material on a surface    thereof that is distal from the first surface relative to the    contact area which is configured to displace the load of the fluidly    sealed chamber edge over the second surface when a therapeutic level    of negative pressure is applied,-   wherein cushion surface is configured to approximately conform to a    contact area defined by approximately the gonion on one side of the    mandibular body, across the mental protuberance, and to the opposite    gonion of the mandibular body, and from approximately the gonion on    one side of the mandibular body to a position on the neck at the    level of the thyroid cartilage, and to the opposite gonion of the    mandibular body.

In a related aspect, the present invention relates to devices configuredfor the administration of negative pressure upon the external surface ofthe individual, comprising:

-   a vessel configured to define a chamber at an external location    approximately at the internal soft tissue of the individual    corresponding to the anterior triangle of the neck;-   a cushion element defining a contact area between the individual and    the vessel, the cushion element comprising a first surface thereof    configured to make contact with the skin of the individual when the    therapy device is mated to the individual, and a second surface    there of that is distal from the first surface relative to the    contact area and that, together with the first surface, forms a    fluidly sealed chamber;-   An adhesive layer positioned on the exterior of said first surface    to make contact with the skin of the individual when the therapy    device is mated to the individual,-   a non-flowing material positioned within the fluidly sealed chamber,    the non-flowing material configured to provide mechanical support to    the fluidly sealed chamber to prevent regional collapse of the    fluidly sealed chamber when the therapy device is mated to the    individual and a therapeutic level of negative pressure is applied    within the vessel;-   a ribbon layer positioned to the non-flowing material on a surface    thereof that is distal from the first surface relative to the    contact area which is configured to displace the load of the fluidly    sealed chamber edge over the second surface when a therapeutic level    of negative pressure is applied,-   wherein cushion surface is configured to approximately conform to a    contact area defined by approximately the gonion on one side of the    mandibular body, across the mental protuberance, and to the opposite    gonion of the mandibular body, and from approximately the gonion on    one side of the mandibular body to a position on the neck at the    level of the thyroid cartilage, and to the opposite gonion of the    mandibular body.

In certain embodiments, the first surface of the cushion element and thesecond surface of the cushion element are formed as separate surfacesthat are affixed to one another to form a peripheral joining surface,wherein the peripheral joining surface is configured to not contact theindividual when the therapy device is mated to the individual and atherapeutic level of negative pressure is applied within the vessel. Byway of example, the first surface of the cushion element and the secondsurface of the cushion element may be formed as separate surfaces thatare affixed to one another by RF welding. The first surface of thecushion element and the second surface of the cushion element may beformed from a flexible thermoplastic material such as a thermoplasticpolyurethane.

As described hereinafter, the term “fluidly sealed” refers to a chamberthat retains the fluid contained within the chamber for a period of timerequired for normal use of the chamber. In various embodiments, thefluidly sealed chamber may comprise one or more of the following fluidsealed within the chamber: a gas (e.g., air), a gel, a particulatematerial (e.g., microspheres), a liquid, a foam (e.g., an open cellfoam), etc. This list is not meant to be limiting. As describedhereinafter, one or more materials within the fluidly sealed chamber maybe selected to provide a non-flowing material in order to preventcollapse of the fluidly sealed chamber when in use. Such a non-flowingmaterial may be in the form of an open cell foam having an indentationalforce deflection (IFD) of about 8-40 lbs/50 in², and preferably anindentational force deflection (IFD) of about 12-30 lbs/50 in² or about18-22 lbs/50 in². The term “about” as used herein refers to +/−10% of aspecified value.

In certain embodiments, the contact area of the cushion elementcomprises a gel material applied thereto. By way of example, a gelmaterial may be applied to the contact area to form a tacky surface inorder to resist movement of the cushion element relative to the skin ofthe wearer.

As described hereinafter, a cushion element is preferably configured toprovide an approximately constant contact pressure across the entirecontact area between the individual and the vessel when the therapydevice is mated to the individual and a therapeutic level of negativepressure is applied within the vessel. This contact pressure maypreferably be about 1.1 to 1.3 times the negative pressure within thefluidly sealed chamber. In certain embodiments, the perpendicular widthof the contact area is varied along the peripheral axis of the contactarea such that, when the therapy device is mated to the individual and atherapeutic level of negative pressure is applied within the vessel, theapproximate contact pressure applied to the skin surface isapproximately 1.2 times the negative pressure within the vessel.

In related aspects, the present invention relates to methods of applyingnegative pressure therapy to an individual in need thereof, comprisingmating a therapy device as described herein to the individual, andapplying a therapeutic level of negative pressure within the vessel,thereby increasing patency of the airway of the individual. Such methodscan be for treatment of sleep apnea; for treatment of snoring; fortreatment of full or partial upper airway collapse; for treatment offull or partial upper airway obstruction; for negative pressuretreatment of a wound caused by, for example an injury or a surgery; etc.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of an illustrative embodiment of the vacuumchamber/dome 116, including cushion element 100, with the adhesive layer110, urethane outer layer of the fluidly sealed chamber 111, foam layer112, ribbon layer 113, and inner urethane layer of the fluidly sealedchamber 114.

FIG. 2 is a view of an illustrative embodiment of the vacuumchamber/dome 116, with cushion element 100, with the adhesive layer 110,peripherally joined surface(s) 115 and location of cross-sectional view117.

FIG. 3 is cross-sectional view 117 of an illustrative embodiment of thetherapy device with the cushion element 100, with the adhesive layer110, urethane outer layer of the fluidly sealed chamber 111, foam layer112, ribbon layer 113, urethane inner layer of the fluidly sealedchamber 114, peripheral joining surface(s) 115 vacuum chamber 116.

FIG. 4. is a three dimensional rear view of an illustrative embodimentof the vacuum chamber/dome 116 including the cushion element 100 with avertical bisecting line 118 for illustration purposes in FIG. 5.

FIG. 5 is a two dimensional rear view of an illustrative embodiment ofhalf the therapy device, bisected along the vertical axis 118 and FIG.5, 118, showing the flattened half of the chamber/dome 116 including aflattened cushion 100, the cushion element further having a dashed line119 approximately following the curvature of the cushion as an exampleof a contact location of the vacuum chamber dome on the opposite side ofthe cushion element and the contact surface of the cushion elementdivided into stations 1-20 for graphical representation in FIG.6.

FIG. 6 is a graphical representation of (1) the station load alongstations 1-20 in FIG. 5 without a cushion element present 120, (2) agraphical representation of a cushion configured to accommodate stationloads along contact stations 1-20 where design elements of the cushion(for example, decreasing perpendicular width and subsequent sectionarea, approaching and through stations 8-13) increases pressure atstations 8-13 toward the end of the oval 121 and (3) a graphicalrepresentation the equalized station load upon application of thecushion element 100 to the chamber 116 showing alleviation of stationpressure variation due to design attributes of cushion element 122.

FIG. 7A is a cross-sectional view 117 of an illustrative embodiment ofthe cushion element 100 containing an adhesive layer 110, outer layer ofthe fluidly sealed chamber 111, the foam layer element 112 and ribbonlayer element 113.

FIG. 7B is a cross-sectional view 117 of an illustrative embodiment ofthe cushion element 100 containing an adhesive layer 110, a primer layer123, the outer layer of fluidly sealed chamber 111, the foam layerelement 112 and the ribbon layer element 113.

FIG. 7C is a cross-sectional view 117 of an illustrative embodiment ofthe cushion element 100 containing an adhesive layer 110, the outerlayer of the fluidly sealed chamber 111, the foam layer element 112, theribbon layer element 113, a primer layer 123 and an adhesive promotinglayer 124,

FIG. 7D is a cross-sectional view 117 of an illustrative embodiment ofthe cushion element 100 with an adhesive layer containing a hydrogelcenter layer 125 and silicone gel peripheral layer(s) 126, the outerlayer of the fluidly sealed chamber 111, the foam layer element 112 andthe ribbon layer element 113.

FIG. 7E is a cross-sectional view 117 of an illustrative embodiment ofthe cushion element 100 with an adhesive layer containing a hydrogelcenter layer 125 and silicone gel peripheral layer(s) 126, the outerlayer of the fluidly sealed chamber 111, the foam layer element 112, theribbon layer element 113 and a primer layer 123.

FIG. 7F is a cross-sectional view 117 of an illustrative embodiment ofthe cushion element 100 with an adhesive layer containing a hydrogelcenter layer 125 and silicone gel peripheral layer(s) 126, the outerlayer of the fluidly sealed chamber 111, the foam layer element 112, theribbon layer element 113, a primer layer 123 and an adhesive promotinglayer 124.

FIG. 7G is a cross-sectional view 117 of an illustrative embodiment ofthe cushion element 100 with an adhesive layer containing a silicone gelcenter 126 and silicone gel outer layers 126 and hydrogel layers 125peripheral to the center silicone gel layer and bordered by the outersilicone gel layers, the outer layer of the fluidly sealed chamber 111,the foam layer element 112 and the ribbon layer element 113.

FIG. 7H is a cross-sectional view 117 of an illustrative embodiment ofthe cushion element 100 with an adhesive layer containing a silicone gelcenter 126 and silicone gel outer layers 126 and hydrogel layers 125peripheral to the center silicone gel layer and bordered by the outersilicone gel layers, the outer layer of the fluidly sealed chamber 111,foam layer element 112, the ribbon layer element 113 and a primer layer123.

FIG. 7I is a cross-sectional view 117 of an illustrative embodiment ofthe cushion element 100 with an adhesive layer containing a silicone gelcenter 126 and silicone gel outer layers 126 and hydrogel layers 125peripheral to the center silicone gel layer and bordered by the outersilicone gel layers, the outer layer of the fluidly sealed chamber 111,foam layer element 112, the ribbon layer element 113, a primer layer 123and an adhesive promoting layer 124.

FIG. 7J is a cross-sectional view 117 of an illustrative embodiment ofthe cushion element 100 with an adhesive layer 110 with primer layerslocated at the corners of the outer layer of the fluidly sealed chamber111, the foam layer element 112 and the ribbon layer element 113.

DETAILED DESCRIPTION OF THE INVENTION

The present invention and the various features and advantageous detailsthereof are explained more fully with reference to the non-limitingembodiments that are illustrated in the accompanying drawings anddetailed in the following description. It should be noted that thefeatures illustrated in the drawings are not necessarily drawn to scale.Descriptions of well-known components and processing techniques areomitted so as to not unnecessarily obscure the present invention. Theexamples used herein are intended merely to facilitate an understandingof ways in which the invention may be practiced and to further enablethose of skill in the art to practice the invention. Accordingly, theexamples should not be construed as limiting the scope of the invention.In the drawings, like reference numerals designate corresponding partsthroughout the several views.

In the present invention, a cushion element is designed for a negativepressure therapy device that maximizes comfort and seal efficiencyultimately optimizing device efficacy and user compliance. The negativepressure therapy device is described below for use in the opening of theupper airway when placed upon the neck of a subject over a surfacecorresponding to approximately the upper airway of the subject. Thisexemplary application of the technology is not meant to be limiting. Thecushion element portion of the devices described herein is configured toprovide for regional load equalization over the interface between anegative pressure therapy device and the three dimensionally varyingskin surface of the user so as to maintain a near uniform contactpressure over this non-uniform surface.

In particular, the therapy device referred to herein relates but is notlimited to an external therapy appliance for relieving upper airwayobstruction. U.S. patent application Ser. No. 12/002,515, 12/993,311 and13/881,836 which are hereby incorporated by reference in their entiretyincluding all tables, figures and claims, describes a therapy appliancefor relieving airway obstruction. Increasing the patency of the upperairway of an individual alleviates conditions such a snoring, sleepapnea, full or partial upper airway collapse. As described therein, adevice is configured to fit under the chin of a user at an externallocation corresponding to the soft tissues overlying the upperrespiratory passages of the neck.

Surface variation of the therapy site, both permanent and occasional(ie, the shape of the mandible, transition points from neck to mandible,tissue types, scars, facial hair and/or skin blemishes differentialforces applied to different portions of the seal caused by movement ofthe wearer, etc.) can undesirably disrupt the seal between the negativepressure therapy device and user. The present invention providesdevices, systems and methods of use that can accommodate varying facialcontours and features, and adapt to movement, resulting in greatercomfort, reduced vacuum leakage and improved therapeutic efficacy.

The cushion element of the sealing surface is adapted to have sectionalproperties that allow for flexibility and uniform regional compliance.As used herein, “uniform regional compliance” refers to a property ofthe cushion element that permits the cushion element to “mold” itself toa surface and or surface variation on the contact surface with thewearer. As described hereinafter, this uniform regional compliance isprovided, in part, by the sectional properties or features associatedwith a region on the cushion element.

The cushion element comprises a fluidly sealed chamber; and a foam layerand/or a semi-rigid ribbon layer housed within the fluidly sealedchamber. The term “fluidly sealed” refers to a chamber that retains thefluid contained within the chamber for a period of time required fornormal use of the chamber. By way of example, a latex balloon is“fluidly sealed” to helium if normal use of the balloon is for 6 hours,despite the fact that over time that helium may ultimately leak from theballoon, and despite the fact that the balloon may burst if put underabnormal conditions.

Optionally an adhesive layer is located on the surface of the cushionelement that makes contact with the user. These elements are configuredto maintain an approximate uniform contact pressure with minimizedpressure variations along the skin of an individual through all pointsof contact of the therapy device on a patient. By “minimized pressurevariation” means a pressure at any point between the contact surface ofthe cushion element and the patient's tissue varies by no more than 20%,and preferably no more than 10% or 5%, from the average pressure acrossthe entire contact surface. The outer contact surface, as used herein,is the surface of the cushion element of the therapy device that makescontact with the skin of the individual forming the contact and sealingsurface of the therapy device.

In certain embodiments, the cushion element of the invention providesthe contact interface of a negative pressure therapy device configuredto conform to the external area of the neck approximately correspondingto the anterior triangle of the neck. Most preferably, the cushionelement is configured to follow the contour of the therapy device whichis designed to approximately conform to an individual from approximatelythe gonion on one side of the mandibular body, across the mentalprotuberance, and to the opposite gonion of the mandibular body andfurther configured to approximately conform to an individual fromapproximately the gonion on one side of the mandibular body to aposition on the neck near the level of the thyroid cartilage, and to theopposite gonion of the mandibular body.

In certain embodiments, the negative pressure therapy device of thepresent invention is a chamber, approximately a dome, oval inappearance, with a curvature from the middle of the dome that creates acollar to cover an area over the upper airway of an individual. Inpreferred embodiments the negative pressure therapy device containsstructural elements adapted to guide correct placement and orientationof the device on the user, for example a chin cup element. As usedherein a “chin cup” refers to a discreet feature on the negativepressure therapy device which provides a recess configured to receivethe chin of the wearer when the negative pressure therapy device isproperly mated to the wearer. During application of the negativepressure therapy device, the chin cup provides a consistent point ofreference on which the negative pressure therapy device can mate withthe wearer. The shape of the chin cup may vary to allow for anatomicalvariation in patients. For example, the chin cup may be somewhat deeperfor use in a subject having mandibular prognathia; somewhat shallowerfor use in a subject having mandibular retrognathia; or somewhat largetin volume for a subject having macrogenia.

In various embodiments, the present invention comprises a symmetricvacuum chamber with a flat contact surface adapted to fit to a flatuniform surfaceand to provide minimized pressure variation throughoutall points of contact when a vacuum is applied. In other variousembodiments, the present invention comprises a vacuum chamber with acontact surface configured to adapt to the inherent anatomicalvariations of an individual's face. The curved, “wraparound” shape thatthe negative pressure therapy device must assume can cause the “stationload” through different contact points to vary in the absence of thedesign features described herein. For example, absent a feature orfeatures designed to accommodate for station load variation, at pointsfurthest from the center of the dome of the therapy device, toward thenarrow end portions of the oval, the station load decreases due to alesser vacuum cross section over the contact point(s). As used herein,“station load” is the force or pressure which is applied at a discreetarea of contact of the device (a “station”) on the skin of an individualwhen the device is mated to the individual and a therapeutic level ofnegative pressure is applied.

As discussed herein, the cushion element of the instant invention formsthe interface between the dome/chamber of the therapy device and thecontact surface of the individual. The cushion element comprisesstructural features that provide minimized pressure variation atstations where contact pressure variation can occur as a result ofeither anatomical variation, tissue variation, inherent therapy devicedesign, and or movement during usage. The cushion element therebyproviding features to the therapy device to minimize peak contactpressure values, minimize the variance from station to station andequalize the contact pressure of the therapy device when a therapeuticlevel of negative pressure is applied to provide an effective seal.

The term “seal” as used in this context is not to necessarily imply thata perfect seal is formed between the therapy device and the contactsurface of the individual. Rather, a “seal” is a portion of the devicewhich mates to the wearer and maintains a therapeutic level of vacuum. Acertain amount of leakage at the seal may be tolerated so long as thedesired negative pressure can be achieved and maintained. Preferredoperational vacuum levels are in a range of between 7.6 cm to about 61cm of water. Preferred forces applied to the user's neck tissues inorder to assist in opening the upper airway passages are in a range ofabout 0.5 kilogram to about 6.68 kilograms.

The chamber enclosed by the dome provides a finite volume which must beevacuated to deliver the desired partial vacuum level. Once generated,the partial vacuum will decay at a rate which is primarily controlled byleakage of air into the chamber past the seal and or features integratedinto the dome to provide airflow. In certain embodiments, the chamberencloses a volume of between 0.5 and 12 in³. Preferably, the leakage isno more than between 0.005 and 0.5 in³/min, and most preferably betweenabout 0.01 and 0.1 in³/min.

The present invention provides both sufficient regional, and overall,compliance of the cushion element such that local bottoming/regionalcollapse of the cushion element does not occur under load. As usedherein, “regional compliance” of the cushion element refers to theability of individual stations of the cushion element to accommodate atherapeutic level of vacuum without complete compression of the fluidlysealed chamber at that station. As used herein, “overall compliance” ofthe cushion element refers to the ability of the cushion element toaccommodate a therapeutic level of vacuum without complete compressionof the fluidly sealed chamber. Further, bottoming or “regionalcollapse”, as used herein, is defined as a complete or near completecompression of the fluidly sealed chamber and material within such thatits resistance to further compression is no longer possible. Thisresults in a hardening of supporting structure(s) by the flexibleportions of the cushion element under a heavy load, and loss of comfortby the wearer.

The cushion element is preferably a certain thickness and width toachieve the desired cushion contact pressure properties and avoidregional collapse. This is accomplished, in certain aspects, by thecross-section of the fluidly sealed chamber being of a substantiallyrectangular shape. The perpendicular width (width) component of thecushion may vary along the peripheral axis of the contact area of thecushion element to accommodate for station load variations due tonon-uniform shape of the therapy device that contains a dome, that isoval in shape and further contains a central bend to accommodate themating surface on the neck of the patient corresponding to approximatelythe upper airway and maintain a constant contact pressure of thenegative pressure therapy device.

Thickness of the cushion may also vary along the contact surface of thetherapy device to accommodate for anatomical variation. As used herein,thick or thin, describes the distance between the surface of the cushioncontacting the individual and surface of the cushion contacting the domeof the vacuum chamber of a negative pressure therapy device. As usedherein, perpendicular width describes the distance between the inner andouter edges of the cushion element. These dimensions gives the cushiontruss-like properties such that if the cushion element is too thin,though it may be very flexible it will have little to no cushioningproperties, can bottom out creating point(s) of high contact pressureresulting in leaks and/or discomfort. If the cushion element is toothick it will affect its ability to change direction for example beunable to conform to the acute change from the surface of the neck overthe mandible toward the ear for example and further allow for anundesirable level of sheer or lateral movement.

In a similar fashion, if the width of the cushion element is too smallit can create a point(s) of high pressure and too wide it may createunnecessary bulk affecting fit and effective therapy area. In apreferred embodiment of the device the cushion element is approximately28 mm wide and approximately 6 mm thick, where this aspect ratiominimizes positional instability and optimizes flexibility.

“Contact pressure” as used herein, refers to a pressure value dependenton the vacuum present as well as the perpendicular width and surfacearea of the contact surface. A larger “perpendicular width” of a contactsurface (meaning the direction that is perpendicular to the longest axisof the contact surface, which longest axis may be curved) will have alower overall contact pressure under the same vacuum pressure as acontact surface with a smaller perpendicular width due to the increasedsurface area at that particular station of the contact surface.Therefore in regions where the dome station pressure load is low, thecontact surface of the cushion can be designed to be of a smallerperpendicular width to effectively increase and “balance” the contactpressure and in regions where the dome station pressure is high, thecontact surface of the cushion can be designed to be of a largerperpendicular width to effectively decrease and balance the contactpressure where the dome station load is high.

The term “balance” refers to the contact pressure of the therapy devicebeing approximately equal at each station of the contact surface. Thiscontact pressure is proportional to therapy vacuum levels relative tothe contact area of the therapy device. For example, in a comparison, alarger contact area vs a smaller contact area, under the same therapyvacuum level will provide for lower contact pressure of the therapydevice respectively. In an embodiment of the invention the contact areaof the cushion relative to the therapy area provides for a contactpressure that may range from approximately 0.9 to approximately 1.5times the vacuum level and in a preferred embodiment the contactpressure of the cushion element is approximately 1.2 times greater thantherapy vacuum levels.

The cushion element provides a fluidly sealed chamber made of athermoplastic material that may include, for example, thermoplasticpolyurethane (TPU), PVC, PVDC, EVA, PET, nylon and other resins. In apreferred embodiment the fluidly sealed chamber is made of TPU. The TPUfilm is of a thickness that ranges approximately from about six to abouttwelve thousands of an inch and subsequent thermal forming may draw downfinal thickness to as low as about two thousands of an inch.

The urethane material may be selected from a group that are lubricant,wax and/or inorganic filler-free, thus allowing for better adhesion of,for example, an adhesive gel-like layer. The TPU film, further may alsocontain a matte or textured surface to also aid in adhesion of anadhesive gel-like layer. The fluidly sealed chamber may be formed usingmultiple sheets of urethane film that are cut to span the contact areaof a therapy device. The multi sheet method allows for the insertion ofadditional cushioning elements or features and the sheets are affixed toone another using any suitable method, for example the use of pressuresensitive adhesives, gluing and/or RF welding.

In preferred embodiments the TPU layers are affixed to one another tocreate a peripheral joining surface. As used herein, “peripheral joiningsurface” refers to the edge created by the joining of the TPU layersthat create the fluidly sealed chamber. In preferred embodiments theperipheral joining surface is configured furthest away from contact areaof the therapy device such that when the therapy device is mated to anindividual and a therapeutic level of negative pressure is appliedwithin the vessel, the peripheral joining surface does not make contactwith the skin. The peripheral joining surface may be sealed using RFwelding. The term “RF Welding” refers to a discreet process ofpermanently bonding thermoplastic materials through the usage ofelectromagnetic energy to produce molecular agitation such that theymelt together forming a bond as strong as the original material.

In certain embodiments the fluidly sealed chamber may contain a neutralor positive air pressure to achieve a desired cushion compliance. Asused herein, “cushion compliance” is the level of displacementachievable by the cushion element of the negative pressure therapydevice. In a preferred embodiment the fluidly sealed chamber containsambient air pressure. As used herein ambient air pressure is defined asthe air pressure at the location of use. In order to achieve ambientpressure of the fluidly sealed chamber at all altitudes, in certainembodiments, the fluidly sealed chamber may provide a valve orre-sealable interface for the inflation or deflation of the fluidlysealed chamber.

In certain embodiments, together or with one or more of the foregoing, amaterial, which will act as an adhesive layer between the cushionelement of the therapy device and the user, is applied to the outercontact surface of the fluidly sealed chamber element of the cushionelement. The purpose of the adhesive layer is to provide a sealing,cushioning and or sheer absorbing element to the cushion element. Asused herein sheer refers to sheer strain which is a deformation of amaterial in which parallel surfaces can slide past one another, forexample the contact surface of the cushion element and the skin of theuser.

The adhesive layer further must preferentially adhere to the outercontact surface of the negative pressure therapy device and provide asufficient level of “tack” such that a releasable mechanical anchoringof the therapy device to the skin of the user is achieved. Tack, as usedherein, refers to a material device at the interface created between theadhesive layer and the device and the skin of the user at the otherinterface created between the user and the device.

The adhesive layer may be applied to the contact surface area of thenegative pressure therapy device in any suitable method including butnot limited to spraying, painting, placing, etc., in single or multiplelayers to achieve the desired cushioning and sealing propertiesincluding but not limited to thickness, hardness and tack for example.In additional embodiments the adhesive layer may be single layer of auniform thickness or a single layer of a non-uniform thickness coveringthe contact surface of the negative pressure therapy device. In furtherembodiments the adhesive layer may contain a series of parallel adhesivebeads spanning the circumference of the contact surface of the negativepressure therapy device wherein the beads can be of a uniform ornon-uniform thickness and of a like or varying adhesive and or gel-likematerial to achieve the desired cushioning and sealing properties.

In certain embodiments the adhesive layer is present on the contactsurface of the negative pressure therapy device at a thickness fallingwithin a range of approximately 0.005-0.060 inches. In certainembodiments the adhesive layer is present on the contact surface of thenegative pressure therapy device at a thickness falling within a rangeof approximately 0.010-0.050 inches. In further embodiments the adhesivelayer is present on the contact surface of the negative pressure therapydevice at a thickness falling within a range of approximately0.020-0.040 inches.

The adhesive layer may be achieved by using various materials, such as,but not limited to gel, elastomer, viscous solutions, foams andmaterials of the like. These materials can be of any chemicalcomposition which provides the necessary end use properties (i.e. tack,firmness, medical clearance, etc.). These materials include, but are notlimited to polyurethanes, silicones, acroylnitrile butadiene styrene(ABS), hydrogels, and the like. In preferred embodiments, the adhesivelayer should have a hardness as measured by ASTM-D2240-00 (AmericanSociety for Testing Materials) of between 0 and 50, more preferablebetween 5 and 30 most preferable between 5 and 15. In certainembodiments the adhesive layer is made of a silicone gel material. Thesilicone can be any organosilicone which yields the desired propertiesalthough polydimethylsiloxane (PDMS) is often chosen.

The adhesive layer may be applied directly to the outer contact surfaceof the cushion element to a desired thickness or in combination withprimer layer(s)and or primer layer(s) in combination with an adhesion orbinding promotor layer(s) to create the adhesive layer to a desiredthickness. As used herein a “primer” is a substance used as apreparatory coating, acting as a joining surface between the contactsurface of the negative pressure therapy device and adhesive layer or anadhesion promoting layer and the adhesive layer. Further, an adhesionpromoting layer is a substance used as a coating to preferentiallyadhere the adhesive layer to the contact surface of the negativepressure therapy device and or the primer layer that is applied to theouter surface of the negative pressure therapy device.

By way of example, a primer layer may be applied to the contact surfaceof the negative pressure therapy device to a thickness of about 0.005inches, followed by an adhesive promoting layer to a thickness ofapproximately 0.005 inches, followed by the application of an adhesivelayer to a thickness of approximately 0.040 inches achieving a finalthickness of approximately 0.050 inches. Aprimer layer may be applieddirectly to the outer contact surface of the negative pressure therapydevice followed by the application of the adhesive layer directly to theprimer to a desired thickness of approximately 0.050 inches. Inadditional embodiments, an adhesive promoter may be applied to thecontact surface of the negative pressure therapy device followed by theapplication of the adhesive layer to a desired thickness ofapproximately 0.050 inches.

In certain embodiments the adhesive layer is a gel layer. As used hereina gel layer is a layer of material that can have properties that aremostly liquid however behave like solids due to the cross-linked natureof its structure. The material chosen for the gel layer may be of acertain cohesive pliable consistency so as to mold to and conform tocomplex shapes for example imperfections in the skin. As used hereincohesive pliable consistency, elasticity or firmness of the gel layer isdefined as the gel layer's ability to flow, mold and stretch andsubstantially return its original shape when not applied to a surface.The material chosen for the gel layer may also be of a certain tack soas to mechanically secure to the contact area. As used herein tack isdefined as the gel's “stickiness” and is the property that allows theimmediate formation of a bond on contact with another surface

The adhesive layer material must adhere sufficiently to the therapeuticdevice such that it stays adhered to the device when the device isremoved from the users' skin. Additionally must have a tack level thatis chosen for appropriate performance at the users skin interface. Thatis, at too great a level of tack removal of the device from the skin canbe difficult, painful or injurious. While insufficient tack can allowthe device to move during use or allow the seal to the skin to openthereby losing the vacuum. The level of tack can be measured by atexture analyzer. For example, using a TA.XT plus with a 7 mm radius and1 inch diameter spherical head the peak adhesion values should be in arange of 200 to 400 grams peak force more preferably 250 to 350 gramspeak force and most preferably 275-325 grams peak force.

As discussed above the tack of the adhesive layer is optimized toachieve a releasable but mechanical anchor of the therapy device to thepatient. In certain embodiments the contact surface of the fluidlysealed chamber is coated with a primer to preferentially anchor theadhesive layer to the negative pressure therapy device over the contactregion of the user.

In certain embodiments the adhesive layer is formed from a washablesilicone gel such that when washed and allowed to dry, the adhesivelayer returns towards an initial tack. In certain embodiments thesilicone gel is chosen from a group with properties that can becontrolled including, but not limited to: cross sectional thickness,degree of crosslinking (and thereby firmness and tack) and viscosity (soas to be processable under desired conditions. As used herein viscosityis measured in cps referring to centipoise (cps) were 1 cps=0.01 g/cm/s.

In an embodiment of the invention the gel layer is a prepared from a twopart platinum cured organosilicone mixture with properties equivalent toa silicone gel base having an uncatalyzed viscosity of about 20,000 cpsand a crosslinker having an uncatalyzed viscosity of about 300 cps. Thefinal firmness (cps) of the cured gel may be increased by increasing theproportion of the crosslinker in the mixture or decreased by loweringthe proportion of the crosslinker in the mix. The tack of the materialcan be increased by decreasing the proportion of crosslinker in themixture or decreased by increasing the proportion of crosslinker in themix. In order to achieve the desired properties using a silicone gelbase of 20,000 cps and a crosslinker of 300 cps, the ratio of siliconegel base to crosslinker may range (in parts by weight) from about10.0:0.01 to about 10.00:10.20

In embodiments of the invention the ratio of 20,000 cps silicone gelbase to 300 cps cross linker may further range from about 10.0:0.01 toabout 10.0:0.5. In other embodiments of the invention the ratio of20,000 cps silicone gel base to 300 cps crosslinker may range from about10.0:0.01 to about 10:0.1. And in further embodiments of the inventionthe ratio of 20,000 cps silicone gel base to 300 cps crosslinker mayrange from about 10.0:0.06 to about 10:0.20

By example of the invention the silicone gel base and the crosslinkerare mixed in desired ratios and placed under vacuum in order to removeany bubbles in the mixed solution (de-gassing). Following de-gassing,the silicone gel solution is applied to the contact surface of thecushion element and allowed to cure. The mixture can achieve full curein approximately 24 hours at room temperature however in someembodiments a full cure of the silicone gel may be achieved in about 5minutes by placing the cushion element contain the silicone gel layer atabout 150° C. The cure temperature may be adjusted to suit limitingelements of the cushion, for example lower melting points of othercushion elements.

In certain embodiments the adhesive layer is made of a hydrogel.Hydrogels are a three dimensional network of crosslinked hydrophilicpolymer chains that can be crosslinked either physically or chemically.Due to the hydrogel materials significant water content, hydrogels canresemble natural soft tissue more than any other type of polymericbiomaterial. In further embodiments the hydrogel layer may be found as ahydrocolloid wherein the colloid particles are hydrophilic polymersdispersed in water.

In certain embodiments the adhesive layer is made of a combination ofmaterials applied side-by side on the outer contact surface of thefluidly sealed chamber. By way of example, a hydrogel material may beapplied to the circumference of the center portion of the outer contactsurface of the fluidly sealed chamber and a silicone gel material may beapplied on either side peripheral to the hydrogel material. In furtherembodiments where a combination of materials are applied side-by-side onthe outer contact surface of the fluidly sealed chamber, a silicone gellayer may be applied to the circumference of the center portion of theout contact surface of the fluidly sealed chamber and a hydrogelmaterial may be applied to either side peripheral to the silicone gelmaterial followed by a final application of a silicone gel materialperipheral to the hydrogel material.

In certain embodiments the fluidly sealed chamber may contain featuresthat further prevent regional collapse and bottoming. Absent localsupport, a fluidly sealed chamber containing only air may experiencesituations where the air will flow continuously away from a point ofhigh contact pressure for example displace upon application of a forceon the device or cushion causing a bottoming event. In one aspect thefluidly sealed chamber may be formed with multiple chambers to minimizethe collapsing events. In preferred embodiments, the fluidly sealedchamber may contain a fill layer of a non-flowing material. As usedherein, “non-flowing material” refers to a material that is restrainedfrom movement from a location of high contact pressure to a region oflow contact pressure. By way of example, water or air can be freelydisplaced from a region within in a balloon by squeezing of the region,provided that the material of the balloon is sufficiently compliant soas to permit the remaining volume of the balloon to expand slightly andaccommodate the displaced water or air. However, if the balloon isfilled with a sufficiently “solid” material, that material is restrainedfrom such movement. The non-flowing material may be a compressible,elastic filling material that provides additional support, for examplefilling materials may be liquids, viscous solutions, gels, cross-linkedgels, polymers, spheres, microspheres, suspensions, slurries and foams.

In preferred embodiments of the cushion, the fill layer of the fluidlysealed chamber contains a foam layer element. The foam layer element ishoused inside the fluidly sealed chamber element. The foam layer elementaids in the stabilization of the therapy device as well as providescushioning against high local loads caused by anatomical protrusionsinto the fluidly sealed chamber and/or exterior forces for examplepillows proximal to the mandible placed or moved on to by the individualduring sleep. As used herein, foam is a substance that is formed bytrapping pockets of gas in a liquid or solid. The foam element may be ofa certain porosity, as used herein porosity is the ratio of foam-to-airoften measured in Pores Per Inch (PPI) designating the number of poresin one liner inch of material. The foam element may be of open or closedcell format. As used herein, an open cell foam is a material that canexchange air or liquid upon compression or release of compression on thefoam. As used herein, a closed cell foam is a material in which the gasforms discreet pockets, each completely surrounded by the solidmaterial.

Foam is manufactured by trapping bubbles of air in a plastic material tocreate cells and fall in to two categories, one of flexible foams whichare typically open celled foams and the other of rigid foams which aretypically closed celled foams. In open celled foams, cell walls are notsealed within the foam, allowing gas to pass freely throughout and inand out of the foam. Open celled foams are categorized as foams thatcontain greater that 50% open cells. Closed celled foams are generallyhighly cross-linked polymers that prevent gas movement making for arigid foam. In a preferred embodiment the foam element is open cell foamand of a softness so as to not override the compliance of the fluidlysealed chamber element.

The foam layer element may be chosen from a group containing specificrecovery characteristics. As used herein, recovery is defined as thereturn of a material to its original dimension and properties after adeforming force is removed. The foam layer element may be loosely fittedor may be pre-loaded in the air-bladder element. As used herein,pre-loaded is defined by applying a stress to a material, for examplethe compression or overstuffing of the foam element during manufactureof the air-bladder/cushion to generate added cushion stiffness creatingadditional rate to add regional compliance, prevent bottoming or toprevent wrinkles of the cushion or a combination whole or in part. Asused herein rate is defined as the load in pounds divided by thedeflection in inches. For example, a soft spring has a low rate anddeflects a greater distance under a given load

In a preferred embodiment the foam layer element is a medium density,flexible polyurethane foam containing Indentational Force Deflection(IFD) of approximately 8-40 lbs/50 in². IFD is used in the flexible foammanufacturing industry to assess the “softness” of a sample of foam andmeasured in lbs/50 in² for 25% indentation. As used here in softness isdefined as yielding readily to touch or pressure. IFD is can bedetermined by using ASTM Standard D3575 (American Society for TestingMaterials) where typically a 100 mm thick slab of foam with an area ofapproximately 500 mm by 500 mm is place on a perforated surface and“warmed up” by being compressed twice to 75% strain with a circular flatindenter with a surface area of 323 cm² and then allowed to recover for6 minutes. The IFD is then measured 1 minute after achieving 25%indentation by the indenter. In certain aspects the foam layer elementis an open celled foam with an IFD of 12-30 lbs/50 in2 and in a furtheraspect the foam layer element is an open celled foam with an IFD of18-22 lbs/50 in².

In certain aspects, the device contains a thin ribbon element backingthe foam layer element located between the inner surface of the cushionelement and the foam layer element of the apparatus. The ribbon elementis made of a semi-rigid material and is cut to mimic the shape of thecontact surface of the therapy device. Further, the ribbon element layermay be continuous semi-rigid element or may contain cut-outs to allowfor additional flexibility at desired points. The ribbon layer elementprovides rigidity to the cushion element and is configured to displacethe load of the vacuum chamber/dome edge across the full width of thefluidly sealed chamber and subsequently the contact surface of cushionelement and contact region of the subject when a therapeutic level ofnegative pressure is applied. In a preferred embodiment the ribbonelement is made of a medical grade, USP Class VI compliant, polystyrenematerial.

Elements of the cushion for example, the fluidly sealed chamber, fillingmaterial and ribbon layer may be formed freely wherein the fill materialand ribbon layer within the fluidly sealed chamber contain no specificadhesion to the inside of the fluidly sealed chamber or each other.However in certain embodiments bonding of one or more interior layersmay be preferable to prevent some or all of the cushion elements frommoving inside the fluidly sealed chamber.

As used herein, “user compliance” is the patient's adherence to theprescribed usage of a therapy device for example the usage of a devicethroughout a sleep cycle.

As used herein, “device compliance” refers to the ability of the deviceor elements of the device to accommodate variation, for example,bending, twisting, compressing and or expanding of the device inresponse to device application and usage including anatomical variationsof the patient.

Aspects of the device may be made of a generally rigid material. Theterm “generally rigid” as used herein refers to a material which issufficiently rigid to maintain the integrity of the particular elementin question. The skilled artisan will understand that a number ofpolymers may be used including thermoplastics, some thermosets, andelastomers. Thermoplastic materials become flowing liquids when heatedand solids when cooled, they are often capable of undergoing multipleheating/cooling cycles without losing mechanical properties. Thermosetmaterials are made of prepolymers which upon reaction cure irreversiblyinto a solid polymer network. Elastomers are viscoelastic materialswhich exhibit both elastic and viscous properties and can be either athermoplastic or thermoset. Common thermoplastics include PMMA, cyclicolefin copolymer, ethylene vinyl acetate, polyacrylate,polyaryletherketone, polybutadiene, polycarbonate, polyester,polyetherimide, polysulfone, nylon, polyethylene, and polystyrene.Common thermosets include polyesters, polyurethanes, duroplast, epoxyresins, and polyimides. This list is not meant to be limiting.Functional filler materials such as talc and carbon fibers can beincluded for purposes of improving stiffness, working temperatures, andpart shrinkage.

Aspects of the device may be formed using a number of methods known tothose of skill in the art, including but not limited to injectionmolding, machining, etching, 3D printing, etc. In preferred embodiments,the test device base is injection molded, a process for formingthermoplastic and thermoset materials into molded products of intricateshapes, at high production rates and with good dimensional accuracy. Theprocess typically involves the injection, under high pressure, of ametered quantity of heated and plasticized material into a relativelycool mold—in which the plastic material solidifies. Resin pellets arefed through a heated screw and barrel under high pressure. The liquefiedmaterial moves through a runner system and into the mold. The cavity ofthe mold determines the external shape of the product while the coreshapes the interior. When the material enters the chilled cavities, itstarts to re-plasticize and return to a solid state and theconfiguration of the finished part. The machine then ejects the finishedparts or products.

Those skilled in the art will appreciate that the conception upon whichthis disclosure is based may readily be utilized as a basis for thedesigning of other structures, methods and systems for carrying out theseveral purposes of the present invention. It is important, therefore,that the claims be regarded as including such equivalent constructionsinsofar as they do not depart from the spirit and scope of the presentinvention.

The cushion device of the present invention comprises structuralmember(s) that interfaces outside a targeted therapy area of a patient.In a preferred embodiment the therapy area is that of the upper airway.The therapy device contains a vacuum chamber/dome 116 that is used tocreate a vacuum between an inner surface of the appliance and the skinof the upper neck/chin region. The vacuum chamber/dome 116 is secured toa cushion element 100 at a single point along the back of the cushion119 that evenly distributes the force across all of the cushion element.The device may be formed, molded, or fabricated from any material orcombination of materials. Non-limiting examples of such materialssuitable for constructing the therapy appliance include plastics,metals, natural fabrics, synthetic fabrics, and the like. The device mayalso be constructed from a material having resilient memory such as, butnot limited to, silicone, rubber, or urethane.

In an embodiment of the invention, as can be seen in FIG. 3. showing across-sectional view 117 of the negative pressure therapy device, thedevice contains a cushion 100 in the form of an fluidly sealed chambercontaining an inner urethane layer 114, an outer urethane layer 111, anadhesive layer 110 applied to the outer urethane layer 111. The cushionfurther consists of a foam layer 112 located inside the fluidly sealedchamber and a semi-rigid ribbon layer 113 as a backing to the foam layer112. The adhesive layer 110 is preferably made of a biocompatible,non-toxic material to act as a mechanical anchor to inhibit motion ofthe device that could cause leakage of negative pressure and further,formation of skin damage for example blisters. The adhesive layer is ofa thickness and tack selected so as to flow into surface anomalies tocreate and maintain an optimal seal and self-repair through multipleapplications and removals.

The adhesive layer 110 is affixed to the cushion element 100independently or in combination with one or more layers of material tofor example a primer layer 125 and or an adhesion promoting layer 126 toachieve the desired preferential adhesion of the adhesive layer to thedevice while providing the desired releasable mechanical anchoring,sealing and cushioning properties of the adhesive layer to the user.Additionally, the releasable mechanical anchoring, sealing andcushioning properties of the adhesive layer 110 may be achieved by usinga single adhesive material or a combination of materials.

FIG. 7a-7c show cross-sectional views (FIG. 3, 117) of the cushionelement 100 with varied arrangements of materials making up the adhesivelayer 110. For example, FIG. 7a shows a design wherein the cushionelement 100 contains a single adhesive layer 110 located directly on theouter contact surface of the cushion element 100. In additionalembodiments, FIG. 7b shows a design where the cushion element 100contains a primer layer 123 located between the outer contact surface ofthe cushion element 100 and the single adhesive layer 110. And in yet afurther embodiment, FIG. 7c shows a design where the cushion element 100contains a primer layer 123 located on the outer surface of the cushionelement 100 and an adhesive promoting layer 124 located between theprimer layer 123 and the adhesive layer 110. The single adhesive layerelement 110 being made of a silicone gel 125, a hydrogel 126 or anymaterial of the like.

In an embodiment where the adhesive layer contains varied layers ofmaterials, the application of a primer layer, adhesive promoting layeror both may be confined to regions where the greatest stress fromrepeated application and removal of the negative pressure therapy deviceis observed. For example, FIG. 7j shows a cross sectional view of thecushion element (FIG. 3, 117) wherein the cushion element 100 contains aprimer layer 123 located on the outer corners of the contact surface ofthe cushion element 100 and an adhesive layer 110 spanning the contactsurface of the cushion element 100 over the corners of the cushionelement 100 coated with the primer layer 123.

The invention the adhesive layer may contain configurations where variedadhesive materials are placed adjacent to one another on the outercontact surface of the cushion element 100. For example, in FIGS. 7 d, 7e and 7 f, showing a cross-sectional view 117 of the cushion element, ahydrogel layer 126 is applied to the center of the cushion element 100and contains peripheral layers of a silicone gel 126. The aforementionedconfiguration can be applied directly to the outer surface of thecushion element 100 as seen in FIG. 7 d, in a combination with a primerlayer 123 as seen in FIG. 7 e, or in combination with a primer layer 123and an adhesion promoting layer 124 as seen in FIG. 7 f.

Where the adhesive layer contains varied configurations of adhesivematerial, a silicone gel layer 125 may be place in the center of theouter contact surface of the cushion element 100 with peripheral layersof a hydrogel 126 with further peripheral layers of a silicone gel, asseen in FIG. 7 g, FIG. 7h and FIG. 7 i. The aforementioned configurationcan be applied directly to the outer surface of the cushion element 100as seen in FIG. 7 g, in a combination with a primer layer 123 as seen inFIG. 7 h, or in combination with a primer layer 123 and an adhesionpromoting layer 124 as seen in FIG. 7 i.

The cushion element 100 contains an outer urethane layer 111 to which aninner urethane layer 114 is adhered through creating a peripheraljoining surface. The peripheral joining surface 115 creates fluidlysealed joints 115 and an air-tight seal to form the fluidly sealedchamber of the cushion element. The peripherally joining surface(s) 115are created on surfaces of the cushion furthest away from the contactsurface of the therapy area to minimize the possibility of edges of thecontacting the surface of the skin and causing irritation. The spacebetween the inner urethane layer 114 and outer urethane layer 111 form afluidly sealed chamber that contains a fillable volume. The fillablevolume may be span the entirety of the cushion or contain chambers.Further, the fillable volume may contain compressible elastic-typematerials such as air, gel, beads, microspheres, foam, slurries or acombination in partial or in whole.

The fillable volume of the cushion 100 may further contain a foam layerelement 112. The foam layer element may be selected from a range ofdensities for specific regional compliance providing higher or lowerrebound rates further managing the force applied on the contact surfaceof the patient when the therapy device is applied. The foam layer 112may further be backed by a semi-rigid ribbon layer 113. The ribbon layer113 is located inside the cushion 100, toward the inner portion of thetherapy device 116 furthest away from the contact surface of the therapyarea. The ribbon layer displaces the load of the dome/chamber 116 evenlythrough the cushion element.

The cushion 100 is designed to accommodate variations in station loadupon placement of the therapy device on a subject and application of atherapeutic level of negative pressure. This is accomplished by devicedesign and structural elements that anticipate known anatomical featuresas well as structural elements that can accommodate surface variationsthat occur during use. FIG. 4, showing the rear of the therapy devicewith the chamber/dome feature 116 and cushion element 100 has linebisecting the device 118 for purposes of FIG. 5. In order to furthergraphically illustrate the cushioning feature(s) of the device, FIG. 5shows a flattened/two dimensional representation of half of the therapydevice with chamber/dome 116 and cushion element 100, with the bisectingline 118 as seen in FIG. 4 and a dashed line through the center of thecushion 119 showing the approximate location of the chamber/dome on therear of the cushion element. The flattened half of the cushion 100 isapproximately sectioned into 20 stations beginning at station 1, locatedclosest to the upper middle section of the device that makes contactwith the chin of the user, progressing through stations 8-13 travelingover approximately over the mandible and goinion approaching the ear anddown to the neck toward station 20 located at the bottom portion of thehalf of cushion located approximately at the middle of the neck of theuser.

Absent features, for example a cushion (and structural features therein)to balance the contact pressure of the device when a therapeutic levelof negative pressure is applied, a user would experience varied contactpressures, for example, lower contact pressure in regions where thecross section of the dome decreases due to the non-symmetric shape ofthe dome for example at the tips of the oval shaped dome/at the ends ofthe device, specifically through stations 8-13, FIG. 5. Further as canbe seen in FIG. 6, 120, which is a graphical representation of anun-cushioned therapy device with the dome station load in the Y axis andthe station number on the X axis, as one approaches the tip of the ovalas in FIG. 5 stations 8-13 the dome station load decreases.

In certain embodiments the perpendicular width of the cushion element istherefore varied to increase or decrease the contact pressure at certainstations. A decrease in the perpendicular width reduces the segment areaultimately increasing the contact pressure for that section when atherapeutic level of negative pressure is applied. For example in FIG. 5as one approaches stations 8-13 one can see the perpendicular widthdecreases. FIG. 6, 121 further shows a graphical representation of thecushion segment area on the Y axis and the station number on the X axis,as one approaches stations 8-13 the segment area decreases. Therefore,when one combines a known variation in dome station load with a designfeature configured to accommodate the variation a lowest possiblestation pressure variation is achieved.

Cushion balancing may also be accomplished through variation in otherstructural elements of the cushion both locally and throughout thecontact surface, for example foam thickness, foam density, ribbonstiffness, and fluidly sealed chamber pressure alone, whole or in part.In a preferred embodiment the structural elements including the aspectratio of the cushion may change to provide minimal variation in contactpressure wherein the contact pressure is approximately 1.2 times that ofthe applied vacuum at all contact points of the cushion element.

Structural embodiments of the apparatus may vary based on the size ofthe device and the description provided herein is a guide to thefunctional aspects and means.

One skilled in the art readily appreciates that the present invention iswell adapted to carry out the objects and obtain the ends and advantagesmentioned, as well as those inherent therein. The examples providedherein are representative of preferred embodiments, are exemplary, andare not intended as limitations on the scope of the invention.

It will be readily apparent to a person skilled in the art that varyingsubstitutions and modifications may be made to the invention disclosedherein without departing from the scope and spirit of the invention.

All patents and publications mentioned in the specification areindicative of the levels of those of ordinary skill in the art to whichthe invention pertains. All patents and publications are hereinincorporated by reference to the same extent as if each individualpublication was specifically and individually indicated to beincorporated by reference.

The invention illustratively described herein suitably may be practicedin the absence of any element or elements, limitation or limitationswhich is not specifically disclosed herein. Thus, for example, in eachinstance herein any of the terms “comprising”, “consisting essentiallyof” and “consisting of” may be replaced with either of the other twoterms. The terms and expressions which have been employed are used asterms of description and not of limitation, and there is no intentionthat in the use of such terms and expressions of excluding anyequivalents of the features shown and described or portions thereof, butit is recognized that various modifications are possible within thescope of the invention claimed. Thus, it should be understood thatalthough the present invention has been specifically disclosed bypreferred embodiments and optional features, modification and variationof the concepts herein disclosed may be resorted to by those skilled inthe art, and that such modifications and variations are considered to bewithin the scope of this invention as defined by the appended claims.

Other embodiments are set forth within the following claims:

What is claimed is:
 1. A therapy device configured for theadministration of negative pressure upon the external surface of theindividual, the therapy device comprising: a vessel configured to definea chamber at an external location approximately at the internal softtissue of the individual corresponding to the anterior triangle of theneck; a cushion element defining a contact area between the individualand the vessel, the cushion element comprising a first surface thereofconfigured to make contact with the skin of the individual when thetherapy device is mated to the individual, and a second surface there ofthat is distal from the first surface relative to the contact area andthat, together with the first surface, forms a fluidly sealed chamber; anon-flowing material positioned within the fluidly sealed chamber, thenon-flowing material configured to provide mechanical support to thefluidly sealed chamber to prevent regional collapse of the fluidlysealed chamber when the therapy device is mated to the individual and atherapeutic level of negative pressure is applied within the vessel; aribbon layer positioned to the non-flowing material on a surface thereofthat is distal from the first surface relative to the contact area whichis configured to displace the load of the fluidly sealed chamber edgeover the second surface when a therapeutic level of negative pressure isapplied, wherein cushion surface is configured to approximately conformto a contact area defined by approximately the gonion on one side of themandibular body, across the mental protuberance, and to the oppositegonion of the mandibular body, and from approximately the gonion on oneside of the mandibular body to a position on the neck at the level ofthe thyroid cartilage, and to the opposite gonion of the mandibularbody.
 2. A therapy device according to claim 1, wherein the firstsurface of the cushion element and the second surface of the cushionelement are formed as separate surfaces that are affixed to one anotherto form a peripheral joining surface, wherein the peripheral joiningsurface is configured to not contact the individual when the therapydevice is mated to the individual and a therapeutic level of negativepressure is applied within the vessel.
 3. A therapy device according toclaim 2, wherein the first surface of the cushion element and the secondsurface of the cushion element formed as separate surfaces that areaffixed to one another by RF welding.
 4. A therapy device according toclaim 1, wherein the fluidly sealed chamber comprises air sealed withinthe chamber.
 5. A therapy device according to claim 1, wherein thefluidly sealed chamber comprises a gel sealed within the chamber.
 6. Atherapy device according to claim 1, wherein the fluidly sealed chambercomprises particulate material sealed within the chamber.
 7. A therapydevice according to claim 1, wherein the fluidly sealed chambercomprises a liquid sealed within the chamber.
 8. A therapy deviceaccording to claim 1, wherein the contact area comprises a gel materialapplied thereto.
 9. A therapy device according to claim 8, wherein thegel material applied to the contact area forms a tacky surface.
 10. Atherapy device according to claim 1, wherein the first surface of thecushion element and the second surface of the cushion element are formedfrom a flexible thermoplastic material.
 11. A therapy device accordingto claim 10, wherein the flexible thermoplastic material is athermoplastic polyurethane.
 12. A therapy device according to claim 1,wherein the non-flowing material comprises an open-celled foam.
 13. Atherapy device according to claim 12, wherein the open cell foam has anindentational force deflection (IFD) of approximately 8-40 lbs/50 in²14. A therapy device according to claim 12, wherein the open cell foamhas an indentational force deflection (IFD) of approximately 12-30lbs/50in².
 15. A therapy device according to claim 12, wherein the opencell foam has an indentational force deflection (IFD) of approximately18-22 lbs/50 in².
 16. A therapy device according to claim 1, wherein thecushion element is configured to provide an approximately constantcontact pressure across the entire contact area between the individualand the vessel when the therapy device is mated to the individual and atherapeutic level of negative pressure is applied within the vessel. 17.A therapy device according to claim 1, wherein the approximate constantcontact pressure is 1.1 to 1.3 times the negative pressure within thefluidly sealed chamber.
 18. A therapy device according to claim 1,wherein the perpendicular width of the contact area is varied along theperipheral axis of the contact area such that, when the therapy deviceis mated to the individual and a therapeutic level of negative pressureis applied within the vessel, the approximate contact pressure appliedto the skin surface is approximately 1.2 times the negative pressurewithin the vessel.
 19. A method of applying negative pressure therapy toan individual in need thereof, comprising mating a therapy deviceaccording to claim 1 to the individual, and applying a therapeutic levelof negative pressure within the vessel, thereby increasing patency ofthe airway of the individual.
 20. A method according to claim 19,wherein the negative pressure therapy is for treatment of sleep apnea.21. A method according to claim 19, wherein the negative pressuretherapy is for treatment of snoring.
 22. A method according to claim 19,wherein the negative pressure therapy is for treatment of full orpartial upper airway collapse.
 23. A method according to claim 19,wherein the negative pressure therapy is for treatment of full orpartial upper airway obstruction.
 24. A therapy device configured forthe administration of negative pressure upon the external surface of theindividual, the therapy device comprising: a vessel configured to definea chamber at an external location approximately at the internal softtissue of the individual corresponding to the anterior triangle of theneck; a cushion element defining a contact area between the individualand the vessel, the cushion element comprising a first surface thereofconfigured to make contact with the skin of the individual when thetherapy device is mated to the individual, and a second surface there ofthat is distal from the first surface relative to the contact area andthat, together with the first surface, forms a fluidly sealed chamber;An adhesive layer positioned on the exterior of said first surface tomake contact with the skin of the individual when the therapy device ismated to the individual, a non-flowing material positioned within thefluidly sealed chamber, the non-flowing material configured to providemechanical support to the fluidly sealed chamber to prevent regionalcollapse of the fluidly sealed chamber when the therapy device is matedto the individual and a therapeutic level of negative pressure isapplied within the vessel; a ribbon layer positioned to the non-flowingmaterial on a surface thereof that is distal from the first surfacerelative to the contact area which is configured to displace the load ofthe fluidly sealed chamber edge over the second surface when atherapeutic level of negative pressure is applied, wherein cushionsurface is configured to approximately conform to a contact area definedby approximately the gonion on one side of the mandibular body, acrossthe mental protuberance, and to the opposite gonion of the mandibularbody, and from approximately the gonion on one side of the mandibularbody to a position on the neck at the level of the thyroid cartilage,and to the opposite gonion of the mandibular body.